EUCTR2008-002708-25-DE进行中（未招募）不适用
A Randomized, Double-Blind, Placebo-Controlled, Event-Driven Multicenter Study to Evaluate the Efficacy and Safety of Rivaroxaban in Subjects with a Recent Acute Coronary SyndromeThe ATLAS ACS 2 TIMI 51 Trial (The second trial of Anti-Xa Therapy to Lower cardiovascular events in Addition to standard therapy in Subjects with Acute Coronary Syndrome)Amendment INT-2 - The ATLAS ACS 2 TIMI 51 Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 16,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Potential subjects must satisfy the following criteria to be enrolled in the study:
- •Man or woman 18 years of age or older
- •Currently receiving ASA therapy (75 to 100 mg/day) alone or in combination with a thienopyridine (clopidogrel
- •or ticlopidine per national dosing recommendation)
- •Have been hospitalized for symptoms suggestive of ACS that lasted at least 10 minutes at rest, and occurred 48
- •hours or less before hospital presentation or who develop ACS while being hospitalized for an indication other
- •than ACS, and have a diagnosis of:
- •- elevation of ST-segment more than 0.1 millivolt (mV) in 2 or more continuous ECG leads, or new left bundle
- •branch block, or ST segment depression 0.1 mV or greater in 2 of the precordial leads V1 V4 with evidence
- •suggestive of true posterior infarction, all with elevated biomarkers of myocardial necrosis (creatinine kinase
- •muscle and brain isoenzyme [CK-MB] or troponin)
- •- Elevated biomarkers of myocardial necrosis (creatinine kinase-muscle and brain isoenzyme [CK-MB] or
- •troponin) plus 1 of the following:
- •- Transient ST-segment elevation, or ST-segment depression, or T-wave changes consistent with myocardial
- •- Identification of a culprit lesion at coronary angiography demonstrating recent, active intracoronary athero
- •thrombosis (for example, thrombus or an ulcerated plaque
- •- UA with at least 1 of the following:
- •- transient or persistent ST-segment deviation 0.1 mV or greater in 1 or more ECG leads OR
- •- TIMI risk score of =4
- •Subjects who are 18 to 54 years of age inclusive must also have either diabetes mellitus or a prior MI in addition
- •to the presenting ACS event.
- •Women must be:
- •– postmenopausal (for at least 2 years), or
- •– surgically sterile, (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be
- •incapable of pregnancy), or
- •– abstinent (at the discretion of the investigator/per local regulations), or
- •– if sexually active, be practicing an effective method of birth control (e.g., prescription oral contraceptives,
- •contraceptive injections, contraceptive patch, intrauterine device, double-barrier method, male partner
- •sterilization) as local regulations permit, before entry, and must agree to continue to use the same method of
- •contraception throughout the study.
- •Women of childbearing potential must have a negative urine ß-human chorionic gonadotropin (ß-hCG)
- •pregnancy test at screening. Serum pregnancy testing may be performed if required by local regulation.
- •Subjects must have signed an informed consent document indicating that they understand the purpose of and
- •procedures required for the study and are willing to participate in the study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Bleeding risk
- •Any condition that, in the opinion of the investigator, contraindicates anticoagulant therapy or would have an
- •unacceptable risk of bleeding, such as, but not limited to, the following:
- •– active internal bleeding, clinically significant bleeding, bleeding at a noncompressible site, or bleeding diathesis
- •within 30 days of randomization
- •– platelet count <90,000/µL at screening
- •– history of intracranial hemorrhage
- •– major surgery, biopsy of a parenchymal organ, or serious trauma within 30 days before randomization
- •– clinically significant gastrointestinal bleeding within 12 months before randomization
- •– have an International Normalized Ratio (INR) known to be >1.5 at the time of screening
- •– abciximab bolus or infusion within the past 8 hours, or an eptifibatide or tirofiban bolus or infusion within the
- •past 2 hours before randomization
- •– any other condition known to increase the risk of bleeding
- •Severe concomitant diseases such as:
- •Cardiogenic shock at the time of randomization
- •Ventricular arrhythmias refractory to treatment at the time of randomization
- •Calculated creatinine clearance <30 mL/min at screening
- •Known significant liver disease (e.g., acute hepatitis, chronic active hepatitis, cirrhosis), or liver function test
- •(LFT) abnormalities (confirmed with repeat testing) which would require study drug discontinuation, i.e., ALT
- •>5 x ULN or ALT >3 x ULN plus total bilirubin >2 x ULN
- •A prior ischemic stroke or TIA in subjects who are planned to be included in stratum 2 (ASA plus
- •thienopyridine). (Note: Subjects with a prior ischemic stroke or TIA are eligible for inclusion in the study
- •only if they are intended to be treated with ASA only). Subjects with a prior hemorrhagic stroke are excluded
- •completely from the study.
- •Anemia (i.e., hemoglobin <10 g/dL) at screening
- •Known clinical history of HIV infection at screening
- •Substance abuse (drug or alcohol) problem within the previous 6 months
- •Any severe condition that would limit life expectancy to less than 6 months
- •Systemic treatment with strong CYP 3A4 and P-gp inhibitors (e.g., certain azoleantimycotics, such as
- •ketoconazole and HIV protease inhibitors, such as ritonavir). These active substances are strong inhibitors of
- •both CYP3A4 and P-gp.
- •Allergy or hypersensitivity to any component of rivaroxaban or placebo excipients (includes lactose,
- •microcrystalline cellulose, magnesium stearate, hypromellose, macrogol, croscarmellose sodium, sodium lauryl
- •sulfate, titanium oxide)
- •Known aspirin allergy
- •Atrial fibrillation excluded except for subjects younger than 60 years of age who have no clinical or
- •echocardiographic evidence of cardiopulmonary disease and who had only a single episode of atrial fibrillation
- •that occurred more than 2 years ago.
- •Other conditions requiring long-term anticoagulation
- •Use of disallowed therapies (see Section 8, Prestudy and Concomitant Therapy)
- •Received an investigational drug or used an investigational medical device within 30 days before the planned
- •start of treatment, or are currently enrolled in an investigational study
- •Anticipated need for chronic (more than 4 weeks) therapy with non steroidal anti-inflammatory drugs (NSAIDs)
- •Is pregnant or breast-feeding or planning to become pregnant during the study
- •Have previously completed or withdrawn from this study
- •Any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the
- •study or prevent the subject from
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